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DAY CREAM REPLENISHING HYDRATOR SPF 25

Dosage form: lotion
Ingredients: OCTINOXATE 6.6g in 100mL, AVOBENZONE 1.7g in 100mL
Labeler: MOSAIC MARKETING PARTNERS LLC
NDC Code: 34022-102

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DAY CREAM REPLENISHING HYDRATOR

ACTIVE  INGREDIENTS:

ETHYLHEXYL METHOXYCINNAMATE 6.6%

BUTYL METHOXYDIBENZOYLMETHANE 1.65%

PURPOSE

SUNSCREEN

OTHER INGREDIENTS: WATER (AQUA), POLYSILICONE-14, BUTYLENE GLYCOL, PHENOXYETHANOL, ETIDRONIC ACID, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, C12-15 ALKYL BENZOATE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, HYDROGENATED POLYDECENE, TRIDECETH-10, PROPYLENE GLYCOL, GLYCERYL STEARATE, CETEARYL ALCOHOL, POLYSORBATE 60, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIMETHICONE, PANTHENOL (PROVITAMIN B5), ALOE BARBADENSIS LEAF JUICE, PHOSPHOLIPIDS, RETINYL PALMITATE (VITAMIN A), ASCORBYL PALMITATE (VITAMIN C), TOCOPHERYL ACETATE (VITAMIN E), ETHYLHEXYLGLYCERIN, GLYCINE, C18-22 HYDROXYALKYL HYDROXYPROPYL GUAR, PROLINE, FRAGRANCE (PARFUM), STEARIC ACID, ALLANTOIN, OENOTHERA BIENNIS (EVENING PRIMROSE) EXTRACT, CENTELLA ASIATICA (GOTU KOLA) EXTRACT, RUSCUS ACULEATUS (BUTCHER'S BROOM) ROOT EXTRACT, CALENDULA OFFICINALIS (MARIGOLD) FLOWER EXTRACT, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) EXTRACT, GLYCYRRHIZA GLABRA (LICCORICE) ROOT EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, VITIS VINIFERA (GRAPE) SEED EXTRACT, ALANINE, DISODIUM EDTA. 

KEEP OUT OF REACH OF CHILDREN.

AFTER CLEANSING AND APPLYING APPROPRIATE CHELLA SERUM, MASSAGE INTO FACE, NECK AND DECOLLETE.

USE TO TO PREVENT SUNBURN

FOR EXTERNAL USE ONLY

DAY CREAM

REPLENISHING HYDRATOR

SPF 25


DAY CREAM REPLENISHING HYDRATOR  SPF 25
octinoxate avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34022-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE6.6 g  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE1.7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYSILICONE-15 
BUTYLENE GLYCOL 
PHENOXYETHANOL 
ETIDRONIC ACID 
CETOSTEARYL ALCOHOL 
ALKYL (C12-15) BENZOATE 
PROPYLENE GLYCOL 
EDETATE DISODIUM 
GLYCINE 
SODIUM POLYACRYLATE (8000 MW) 
HYDROGENATED POLYDECENE (550 MW) 
TRIDECETH-10 
GLYCERYL MONOSTEARATE 
MEDIUM-CHAIN TRIGLYCERIDES 
GLYCERIN 
POLYSORBATE 60 
DIMETHICONE 
PANTHENOL 
ALOE VERA LEAF 
EGG PHOSPHOLIPIDS 
VITAMIN A PALMITATE 
ASCORBYL PALMITATE 
ALPHA-TOCOPHEROL ACETATE 
STEARIC ACID 
ETHYLHEXYLGLYCERIN 
GUAR GUM 
PROLINE 
ALANINE 
OENOTHERA BIENNIS 
CENTELLA ASIATICA 
RUSCUS ACULEATUS ROOT 
CALENDULA OFFICINALIS FLOWER 
AESCULUS HIPPOCASTANUM LEAF 
GLYCYRRHIZA GLABRA 
GREEN TEA LEAF 
VITIS VINIFERA SEED 
SUNFLOWER OIL 
ALLANTOIN 
Packaging
#Item CodePackage Description
1NDC:34022-102-121 TUBE (TUBE) in 1 BOX
1NDC:34022-102-0250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/21/2012
Labeler - MOSAIC MARKETING PARTNERS LLC (143735186)
Registrant - MOSAIC MARKETING PARTNERS LLC (143735186)

Revised: 01/2012
Document Id: dd8f4566-e8ae-4cd5-ae41-60017d644faf
Set id: e3275796-1e15-45a6-babd-018af9544118
Version: 2
Effective Time: 20120125
 
MOSAIC MARKETING PARTNERS LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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